Dr. Marlowe Schaeffer-Polk, attorney, physician and founder of Medlawguard, and Mr. John Steinbach, Chief Technical Officer and co-founder of Medlawguard, a healthcare risk mitigation firm, discuss the recent Draft Guidance on Mobile Medical Applications.
Marlowe and John:
Examine the scope of the guidance, and highlight what are/are not regulated by FDA
Distinguish between Medical Devices and Mobile Medical Applications
Clarify the three categories of Mobile Medical Applications
Share some potential risks they pose to patients and providers
This interview was conducted by Dr. Jack Varga, Physician Informaticist, Veterans Health Administration.